Reliability and clinical applicability of a novel tear film imaging tool

PURPOSE: The aim of our research was to investigate the reliability and clinical applicability of a modern tear film imaging tool by comparing the inter- and intragrader difference. The further goal was to compare the non-invasive tear break-up time (NIBUT) measured with the LacryDiag® device with traditional tear film break-up time (TBUT). METHODS: Comprehensive ophthalmological examination was performed, including LacryDiag® (Quantel Medical, France) (lower tear meniscus height measuring (LTMH), superior and inferior eyelid meibography (MeibS MeibI), interferometry (INT), NIBUT), slit lamp examination, and TBUT. Two independent, well-trained graders selected and analyzed the LTMH, MeibI, MeibS, and INT. The second grader reanalyzed the data 1 month later. Intra- and inter-examiner reliabilities were evaluated using intraclass correlation coefficients (ICC), while for categorical variable, Cohen’s kappa statistics were provided. The Bland-Altman plot was used for visualization of the agreement between measurements. RESULTS: Fifty healthy volunteers were examined. For LTMH both the inter- and intragrader variabilities were excellent. Between two graders, the ICC of MeibI was poor; however, between two graders, the ICC of MeibS was good, and the intragrader variability in MeibI and MeibS was excellent. For the INT, both intra- and intergrading were in fair and moderate agreement, although the intragrader agreement was higher. Comparing the NIBUT and TBUT, the agreement was slight. CONCLUSION: Based on our results, examination of a patient during follow-up should be performed by the same examiner, because of the slight agreement. The LacryDiag® is a non-invasive, easy-to-use device, which can examine the tear film and save the recordings for easier follow-up.